DOXERCALCIFEROL | N208614 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Denial Letter Final response for Suitability Petition from FDA CDER to Gland ... FDA-2020-P-1859 Gland Pharma Limited filed a suitability petition requesting permission to submit an ANDA for Doxercalciferol Injection at a higher strength of 10 mcg/5 mL, referencing the listed drug Hectorol® Injection approved under NDA 021027. The FDA denied the petition under section 505(j)(2)(C) of the Federa | Suitability | 2022-02-03 | Open | FDA CDER to Gland Pharma Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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